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Abstract:

A controller is provided for a functional electrical stimulator for
attachment to a leg comprising, a connector for a foot switch for sensing
foot rise or foot strike, a circuit for responding to said foot switch
for generating stimulation pulses and a connector for first and second
electrodes for attachment to the leg for supplying stimulation pulses
from said circuit The circuit includes a voltage divider of which the
foot switch when connected comprises one element, a second element being
provided by a digital potentiometer forming part of the controller. A
micro controller is configured to make adaptive adjustment of the
resistance of said digital potentiometer to take account of the
resistance characteristics of the foot switch to provide an output or
reference voltage permitting an open/closed state of the switch to be
monitored. In an embodiment, manually operable external control devices
form part of said controller and the micro controller is configured on
operation of said external control devices to change between a working
state in which stimulation pulses are provided depending on the state of
the foot switch and a setup state for entry using the external control
devices of parameters defining characteristics of the stimulation pulses.

Claims:

1. A controller for a functional electrical stimulator for attachment to
a leg comprising: a connector for a foot switch for sensing foot rise or
foot strike; and a circuit for responding to said foot switch for
generating stimulation pulses; a connector for first and second
electrodes for attachment to the leg for supplying stimulation pulses
from said circuit, said circuit including a voltage divider of which the
foot switch when connected comprises one element, a second element being
provided by a digital potentiometer forming part of the controller; and a
microcontroller configured to make adaptive adjustment of the resistance
of said digital potentiometer to take account of the resistance
characteristics of the foot switch to provide an output or reference
voltage permitting significant changes in the state of the switch to be
monitored.

2. The controller of claim 1, wherein the microcontroller has an A/D
converter input and the output of the voltage divider is connected to
that input.

3. The controller of claim 1, further comprising an output circuit having
a second digital potentiometer controlled by the microcontroller for
controlling the magnitude of the electrical stimulus applied to the leg.

4. The controller of claim 3, wherein said electrodes are active and
indifferent electrodes and the output circuit includes an H-bridge
switchable to reverse the active and indifferent electrodes by reversing
the polarity of the pulses.

5. The controller of claim 4, configured to reverse the polarity
progressively in a multiplicity of steps.

6. The controller of claim 4, wherein the microcontroller is configured
to apply control pulses to the H-bridge at a frequency in the kHz or MHz
range.

7. The controller of claim 6, wherein the microcontroller is configured
to apply control pulses to the H-bridge at a frequency of 200 kHz-10 MHz.

8. The controller of claim 1, wherein the microcontroller is configured
to control the envelope shape of the pulses applied to the body using
pulse width modulation.

9. The controller claim 1, wherein the microcontroller is configured to
generate pulses for delivery in at least first and second channels and to
supply the pulses through the first and second channels by optically
switching a relay having first and second outputs through which
electrodes of the first and second channels are connected.

10. The controller of claim 9, including a microcontroller configured to
apply control pulses to the relay at a frequency of 200 kHz-10 MHz.

11. The controller of claim 1, wherein the microcontroller is configured
to generate pulses for delivery in first to fourth channels and to supply
pulses to a first optically switched relay having first and second
outputs and to second and third optically switched relays connected
respectively to the first and second outputs of the first relay and
providing outputs for the first to fourth channels.

12. The controller claim 1 having controls operable to cause the
microcontroller to change between a working state and a setup state of
parameters defining characteristics of the stimulation pulses.

13. (canceled)

14. The controller of claim 1, further comprising a foot switch.

15. The controller of claim 14, wherein the foot switch is a
force-sensitive resistor whose value reduces from a maximum of about 20
MΩ to a minimum of about 2 kΩ when force is applied to it.

16. (canceled)

17. A controller for a functional electrical stimulator for generating
stimulation pulses for muscles of the human body via active and
indifferent electrodes, said having an output including an H-bridge
switchable to reverse the active and indifferent electrodes by reversing
the polarity of the pulses.

18. (canceled)

19. The controller of claim 17, comprising FETs configured with an output
transformer as the H-bridge, the FET's being biased so as to provide an
output proportional to the signal applied to their gates.

20. (canceled)

21. (canceled)

22. A controller for a functional electrical stimulator for applying
stimulation to muscles of the human body, said controller being
configured to generate pulses for delivery in at least first and second
channels, the controller being configured to supply the pulses through
the first and second channels by optically switching a relay having first
and second outputs through which electrodes of the first and second
channels are connected, and optionally being configured to generate
pulses for delivery in first to fourth channels and to supply pulses to a
first optically switched relay having first and second outputs and to
second and third optically switched relays connected respectively to the
first and second outputs of the first relay and providing outputs for the
first to fourth channels.

23. (canceled)

24. (canceled)

25. (canceled)

Description:

FIELD OF THE INVENTION

[0001] The present invention relates to a functional electrical stimulator
for attachment to the human body for stimulation of one or more muscle
groups. It also relates to the use of the stimulator for treating a
variety of conditions, in embodiments for treating dropped foot.

BACKGROUND TO THE INVENTION

[0002] In embodiments, the invention provides apparatus for applying an
electrical stimulus to a person's leg in timed relationship to leg
movement during walking in order to achieve a benefit.

[0003] For example, a person who has a dropped foot is unable to lift his
or her toes clear of the ground during the swing phase of walking Such a
problem is seen in people who have either a peripheral nerve lesion, as a
result of trauma or disease, or an upper motor neuron lesion. It is the
latter that responds to neuromuscular stimulation. Lesions of the lower
motor neurons result in destruction of the neural pathway so that muscle
contraction can be achieved only through direct stimulation of the muscle
fibers. Functional electrical stimulation may therefore be suitable for
the treatment of patients following stroke, multiple sclerosis, spinal
cord injury T-12 and above, Parkinson's disease, cerebral palsy, head
injury and familial or hereditary spastic paraparesis.

[0004] The first reference to functional electrical stimulation (FES) is
the work by Liberson et al, "Functional electrotherapy in stimulation of
the peroneal nerve synchronized with the swing phase of gait of
hemiplegic patients", Arch. Phys. Med. Rehabil. 42, 202-205 (1961). At
this time electrotherapy was commonplace, but functional electrotherapy
was a new concept. Liberson defined it as follows: ` . . . to provide the
muscles with electrical stimulation so that at the very time of the
stimulation the muscle contraction has a functional purpose, either in
locomotion or in prehension or in other muscle activity. In other words,
functional electrotherapy is a form of replacement therapy in cases where
impulses coming from the central nervous system are lacking.`

[0005] Liberson used a portable stimulator to correct drop foot during
walking A train of pulses of 20-250 μtsec duration, frequency 30-100
Hz and maximum peak current 90 mA was applied through conductive rubber
electrodes. The negative (active) electrode was placed over the common
peroneal nerve below the knee and the large indifferent electrode either
on the thigh or on the lower leg. The stimulator was worn in the pocket
and a heel switch was used to trigger the stimulus during the swing phase
of the gait cycle. The switch was worn within the shoe or on the foot on
the affected side so that the electrical circuit was interrupted during
the stance phase, when the weight was on the heel, and allowed to flow
when the heel was lifted during the swing phase. Liberson was
enthusiastic about the results, reporting that all the subjects
experienced considerable improvement in gait. Despite improvements in the
apparatus used, the basic idea of FES has remained unchanged. Sixteen
papers on the topic published in the period 1960-1977 have been reviewed
by J. H. Burridge et al, Reviews in Clinical Gerontology, 8, 155-161
(1998).

[0006] U.S. Pat. No. 5,643,332 (Stein) is also concerned with FES and
explains that although variants of the technique have been tried and some
success has been obtained, the most common appliance fitted to people
with foot drop is an ankle-foot orthosis (AFO) which is a plastics brace
that fits around the lower leg and holds the foot at close to a
90° angle with respect to the long axis of the leg, and which does
not employ electrical stimulation. Stein gives a number of reasons why
FES had not replaced the AFO, amongst which is unreliability of the foot
switch. In order to overcome this problem, Stein proposes a tilt sensor
for measuring the angular position of the lower leg, although he also
provides a socket for a hand or foot switch for those patients who cannot
use a tilt sensor as there is insufficient tilt of the lower leg. A
muscle stimulator for knee stabilization, also based on a tilt switch, is
disclosed in U.S. Pat. No. 4,796,631 (Grigoryev). Muscle stimulation for
the treatment and prevention of venous thrombosis and pulmonary embolism
is disclosed in U.S. Pat. No. 5,358,513 (Powell III).

[0007] U.S. Pat. No. 6,507,757 (Swain, the contents of which are
incorporated herein by reference) is concerned with improving the
reliability of the foot switch. In one aspect it discloses a functional
electrical stimulator for attachment to a leg comprising:

[0008] first and second electrodes for attachment to the leg to apply an
electrical stimulus;

[0010] a circuit responsive to said foot switch for generating stimulation
pulses; and

[0011] means forming part of said circuit for responding to changes in the
resistance characteristics of said foot switch by adjusting a
corresponding response threshold of said circuit.

[0012] In an embodiment the value of said force-sensitive resistor reduces
from a maximum of about 20 MΩ to a minimum of about 2 kΩ when
force is applied to it. The force-sensitive resistor in an embodiment has
an active portion comprising an array of fingers in contact with a
conductive pad so that mechanical pressure urging the pad towards the
fingers reduces the resistance of the switch, the fingers being of a
first conductive material e.g. a silver based material and having leads
also of said first conductive material, said leads being covered by a
second conductive material e.g. a carbon-based material. In an embodiment
the circuit comprises potentiometer and a footswitch of variable
impedance relative to loading, arranged to form a potential divider. The
voltage produced at the point between the two components is measured and
tracked when the circuit has been energized. A tracking algorithm is used
to determine when the footswitch has been unloaded as the foot is raised
from the ground and reloaded when the foot is planted back down.
Provision has been made to enable this circuit to be de-energized when
the stimulator is placed into sleep mode. Two-channel electrical
stimulation is described in GB-A-2368018 (Swain) e.g. for the treatment
of bilateral dropped foot.

[0014] In one aspect the invention provides a controller for a functional
electrical stimulator for attachment to a leg comprising a connector for
a foot switch for sensing foot rise or foot strike, and a circuit for
responding to said foot switch for generating stimulation pulses, a
connector for first and second electrodes for attachment to the leg for
supplying stimulation pulses from said circuit, said circuit including a
voltage divider of which the foot switch when connected comprises one
element, a second element being provided by a digital potentiometer
forming part of the controller; and a microcontroller configured to make
adaptive adjustment of the resistance of said digital potentiometer to
take account of the resistance characteristics of the foot switch to
provide an output or reference voltage permitting an open/closed state of
the switch to be monitored.

[0015] Embodiments of the above controller have a tracking comparator
configured to establish an ambient or threshold level more rapidly than
devices made in accordance with U.S. Pat. No. b 6,507,757 e.g. within
about 3 seconds and thereby providing the possibility of response when
the user takes his or her first step.

[0016] Embodiments of the above controller are for use with active and
indifferent electrodes, in which case the output circuit may include an
H-bridge switchable to reverse the active and indifferent electrodes by
reversing the polarity of the pulses, in embodiments progressively in a
multiplicity of steps e.g. 4, 8, 16 or more steps. The controller may
include a microcontroller is configured to apply control pulses to the
H-bridge at a frequency in the kHz or MHz range e.g. 200 kHz-10 MHz. The
envelope shape of the pulses may conveniently be controlled by pulse
width modulation.

[0017] In further embodiments the microcontroller may be configured to
generate pulses for delivery in at least first and second channels and to
supply the pulses through the first and second channels by optically
switching a relay having first and second outputs through which
electrodes of the first and second channels are connected. It may be
configured to generate pulses for delivery in first to fourth channels
and to supply pulses to a first optically switched relay having first and
second outputs and to second and third optically switched relays
connected respectively to the first and second outputs of the first relay
and providing outputs for the first to fourth channels. The relay or
relays may be controlled by pulses in the kHz or MHz range e.g. at 200
kHz-10 MHz.

[0018] In another aspect the invention provides a controller for a
functional electrical stimulator for attachment to a leg comprising:

[0019] a connector for a foot switch for sensing foot rise or foot strike;

[0020] a circuit for responding to said foot switch for generating
stimulation pulses;

[0021] a connector for first and second electrodes for attachment to the
leg for supplying stimulation pulses from said circuit;

[0022] manually operable external control devices forming part of said
controller; and

[0023] a microcontroller forming part of said controller and configured on
operation of said external control devices to change between a working
state in which stimulation pulses are provided depending on the state of
the foot switch and a setup state for entry using the external control
devices of parameters defining characteristics of the stimulation pulses.

[0024] Instructions stored in the microcontroller are configured in the
setup state to cause a therapist to input patient-specific parameters for
the device in an appropriate pre-determined sequence as indicated below,
these instructions being input by the set of manually operable controls
forming part of the controller itself. The therapist therefore does not
need access to any external device in order to configure the controller
for the requirements of an individual patient. In an embodiment those
instructions include at least output current, rising ramp time, falling
ramp time, output frequency and where more than one footswitch mode is
supported the selected mode.

[0025] In a further aspect the invention provides a controller for a
functional electrical stimulator for generating stimulation pulses for
muscles of the human body via active and indifferent electrodes, said
having an output including an H-bridge switchable to reverse the active
and indifferent electrodes by reversing the polarity of the pulses.

[0026] In a yet further aspect the invention provides a controller for a
functional electrical stimulator for applying stimulation to muscles of
the human body, said controller being configured to generate pulses for
delivery in at least first and second channel by optically switching a
relay having first and second outputs through which electrodes of the
first and second channels are connected. The first channel may be used
for control of dropped foot as before, and the second channel may be
used, for example, for quadriceps stimulation, to stimulate the gluteus
maximus, or to stimulate the triceps and posterior deltoid muscles and
improve arm swing. Optical switching has the advantage that each channel
is isolated and that there is no cross-talk between channels. The
electrodes for the two channels may be connected to the unit via a single
stereo-type socket or the like. Three or four channels may be achieved by
providing a first switching relay and second and optionally third relays
connected to the outputs of the first relay, a second socket being
provided for the additional channels.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] How the invention may be put into effect will now be described, by
way of example only, with reference to the accompanying drawings, in
which:

[0028]FIG. 1 shows diagrammatically a functional electrical stimulator
according to the invention with electrodes applied to the leg and a foot
switch under the user's heel;

[0029]FIG. 2 is a simplified block diagram of a first embodiment of a
control circuit for the stimulator;

[0030]FIG. 3 is a circuit diagram of an output stage of a stimulator
according to an embodiment of the invention configured for reversal of
active and neutral electrodes connected to the stimulator;

[0031] FIG. 4 shows output waveforms from the output stage of FIG. 3 on
reversal of the active and neutral electrodes;

[0032]FIG. 5 shows a device for fitting to an output of a stimulator to
enable a single stimulator to operate in two channels;

[0033]FIG. 6 shows a device for fitting to an output of a stimulator to
enable the device to operate in four channels; and

[0034]FIG. 7 is a simplified flow chart illustrating how a voltage
divider forming part of the control circuit of FIG. 2 is adjusted to
maintain the output at a suitable voltage for monitoring the state of the
foot switch.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

[0035] The apparatus disclosed in FIGS. 1 and 2 is an electronic device
designed to assist people who have a dropped foot due to neurological
damage that inhibits walking As previously explained, a dropped foot, the
inability to lift a foot whilst walking, resulting in the foot being
dragged forward or swung out to the side, is a common disability
following neurological injury. By stimulating the common peroneal nerve
at its most superficial point, passing over the head of the fibula bone,
it is possible through excitation of the withdrawal reflex to cause
dorsiflexion with degrees of hip and knee flexion. If this is timed with
walking using a foot switch worn in the shoe, walking can be
significantly improved. The stimulus gives rise to a sensation like "pins
and needles" and the patient soon becomes used to it. The apparatus can
be made of size e.g. 72×62×26 mm and of weight 112 g
including e.g. a PP3 internal battery. It can therefore be small and
light enough to be worn in the pocket or on a belt clip. Wires worn under
the clothing carry the electrical stimulus to self-adhesive skin surface
electrodes on the side of the leg. A small foot switch is placed in the
shoe under the heel. The apparatus can be used as an assistive aid or as
a training device to strengthen the muscles and achieve voluntary
control. Additionally the device has a role in physiotherapy gait
re-education, allowing isolated components of the gait cycle to be
practiced under the supervision of a therapist. Dorsiflexion and eversion
in the swing phase of walking produces reduced tripping and falls,
reduced compensatory activity, reduced effort of walking and improved
walking speed and a reduction in patient anxiety and depression. The unit
is not restricted to the treatment of dropped foot, however, and it may
be useful in the treatment of [0036] gluteal or quadriceps muscles in
walking [0037] gluteal or quadriceps muscles for training weight transfer
or sit-to-stand [0038] hamstrings for increased knee flexion or reduced
knee hyperextension [0039] calf muscles for push-off at terminal stance
[0040] triceps and posterior deltoid for improved arm swing/reduced
associated reaction in gait.

[0041] One way in which the apparatus can be applied to the user's leg is
shown diagrammatically in FIG. 1. The peroneal nerve 10 passes just under
the head of the fibula and bifurcates to form deep and superficial
branches. An active electrode 14 may be placed over the common peroneal
nerve just below the head of the fibula, and an indifferent electrode 16
is located about 5 cm below and slightly medially of the active electrode
over the motor point of the anterior tibialis. This is a standard
position to produce a flexion withdrawal response.

[0042] The positions of the active and indifferent electrodes 14, 16 may
be reversed to change the polarity of the stimulation, and in this
arrangement in some cases eversion can be decreased while still producing
dorsiflexion. The more negative electrode is more effective in producing
stimulation than the more positive electrode so that changing electrode
polarity controls the site of stimulation. Provision may be made to
dynamically vary the polarity across a stream of stimulation pulses such
that dorsiflexion and foot inversion/eversion can be controlled during
each part of the gait cycle. Such reversal of polarity can permit muscle
pairs to be controlled using a single pair of electrodes e.g. to
stimulate the deep and superficial branches of the peroneal nerve. The
deep branch of the peroneal nerve stimulates a group of muscles including
the anterior tibealis which can produce dorsiflexion of the ankle The
superficial branch of the peroneal nerve controls the fibularis longus
muscle (also known as peroneus longus) which when injured gives rise to
inability to evert the foot and the fibularis brevis (peroneus brevis)
muscles and thereby control foot inversion/eversion. The ability to
control two groups of muscles by a single pair of electrodes is
advantageous from the standpoint of patient compliance because patients
find multiple electrodes in the same region of the body tedious to apply.
Up to now it has been usual when it is desired to control an additional
muscle or group of muscles to add an additional pair of electrodes, which
not only increases the amount of equipment that the patient has to wear
but also increases the time spent by the patient in fitting and
positioning the electrodes each morning.

[0043] Foot switch 18 and the electrodes 14, 16 are connected to a control
unit 10 that includes controls and circuitry described below. The foot
switch 18 may be as described in U.S. Pat. No. b 6,507,757 and in an
embodiment comprises a force-sensitive resistor whose resistance reduces
from a maximum of about 20 MΩ to a minimum of about 2 kΩ when
force is applied to it. The parameters of the foot switch change with
time, especially in the harsh environment within a shoe where they are
exposed to warmth and moisture and are subject to loads of about 100 Kg
that in use are applied and removed typically over 104-106
cycles. An ordinary potential divider when used to determine the state of
the switch gives unreliable results, and it is necessary to adjust the
state of the potential divider to take account of these changing
parameters as described below. In embodiments, reliable switching may be
obtained over a large range of resistance changes in the force sensitive
resistor. The voltage divider can be rapidly set when the apparatus is
switched on or taken out of sleep mode.

[0044] A control circuit for the unit 12 is shown in FIG. 2. The unit is
managed by a PIC microcontroller 20 which has a stored program input by a
programming header 21 and aspects of which can be adjusted by a therapist
for an individual patient. An 8-bit microcontroller suffices and may in
an embodiment be a microcontroller of the PIC18F4685 family available
from Microchip Technology Inc which have 96 KB of readable, writeable and
erasable flash program memory, a 10-bit A/D converter, and features that
reduce power consumption and extend battery life. These include a sleep
mode and alternate run modes that permit power consumption during code
execution to be reduced by up to 90%, multiple idle modes including modes
where the CPU runs with its core disabled but peripherals still active
allowing power consumption to be reduced to as low as 4% of normal
requirements. One such mode is for timing sensitive applications, and
allows for fast resumption of device operation with its more accurate
primary clock source, since the clock source does not have to "warm up"
or transition from another oscillator. In a SEC_IDLE mode the CPU is
disabled but the peripherals continue to be clocked from the Timer1
oscillator. In RC_IDLE mode, the CPU is disabled but the peripherals
continue to be clocked from the internal oscillator block using the
INTOSC multiplexer. This mode allows for controllable power conservation
during idle periods. The programming header 21 permits in system
programming of firmware including, as previously explained, parameters
later set by the therapist using the user interface of the device.

[0045] The unit 12 has a number of sockets and controls for the user. A
jack socket is provided for the foot switch 18. An electrode jack socket
of size different from the foot switch socket is provided. A combined
stimulation level and on/off switch 26 enables the contraction strength
to be controlled by adjusting the stimulation pulse width from 10 to 400
μs. The switch 26 in an embodiment takes the form of a control knob
which can be depressed and held down to turn the unit on and can be
rotated clockwise or counterclockwise to increase or decrease the output
level. An output test button 24 enables electrode positions to be tested
by the therapist and by the user and can be used by the therapist when
the stimulator is being used during exercising to practice components of
gait. An output is given when the button is pressed when the apparatus is
being used in heel strike mode or when the button is released if it is
being used in heel rise mode. When testing the condition of the
footswitch is not monitored and so the loading on the switch has no
influence on the test. An output indicator LED 23 flickers when the unit
has been triggered. A pause switch 22 is provided that when the unit is
in walk or exercise mode may be used to start and stop operation of the
unit when pressed puts the apparatus into sleep mode, which will conserve
the battery when the user sits down. To return the unit to its active
state, the user need only press the pause switch 22 again. A bleep is
heard, and then the apparatus again responds to the foot switch. The unit
can only be turned off when its output has been paused, otherwise there
is a risk of it being turned off accidentally while in use. When the
pause button 22 has been depressed to put the unit into pause mode, the
switch is rotated to its minimum position and then depressed. An
advantage of this feature is that when the unit is turned off, the pulse
width setting is reduced e.g. to 1%. The user must reset the level to
resume use of the unit. It has been found in practice that users turn the
device up through the day as their muscles become tired and having to
reset the stimulation level when the device is newly turned on means that
they do not receive an unexpectedly high level of stimulation when they
turn the device on the next day. The recommendation for patients is that
the unit should therefore not be turned off using the control knob
through the day but put into sleep mode using the pause switch.

[0046] When the unit has been turned on and is paused, a setup routine
forming part of the program stored in microcontroller 20 can be accessed.
This may be e.g. by depressing and holding down the switch 26 and within
a predetermined period operating both the pause switch 22 and the test
button 24.

[0047] The first time that the set-up mode is entered after turning on the
device, a setup menu is presented inviting the clinician to select the
condition to be treated e.g. dropped foot or one of the other conditions
set out above. When this selection has been made, the setup routine
progresses to a fine tuning menu shown on display 28 in which the
following parameters are adjusted in the sequence indicated: [0048]
Output current (in an embodiment adjustable between 10 and 100 mA,
default 10 mA with a pulse width of 50%). The user may increase
contraction strength by increasing the pulse width, compensating for day
to day variations in muscle fatigue, electrode position and battery
condition or changes in muscle tone. In FIG. 2, signals from the
microcontroller 20 pass through voltage converter 41, digital
potentiometer 42, a network comprising current limiting resistor 42 and
capacitor 45, filters 40 and output stage 46 to electrodes 14, 16. The
output stage may also be controlled by the microcontroller via lines 44.
In one embodiment the output stage comprises a push-pull converter having
an output transformer whose primary is controlled by a pair of 2N7002 and
IRF7317 FETs and whose secondary is connected across the electrode
socket. In another embodiment shown in FIG. 3, output transformer 50 has
a primary 52 connected into an H-bridge of four FETs 56a-56d and a
secondary 54 for connection to the electrodes. Current may pass through
transistors 56a, 56d on supply of signals to gate inputs 1, or may flow
through transistors 56b, 56c on application of signals to gate inputs 2.
The transistors 56a-56d are pulse width modulated to achieve a desired
waveform and are operated in a region where they exhibit analog-type gate
voltage-response behavior. Modulating pulses are applied to their gates
through lines 44 at frequencies which in some embodiments are in the
range 200 KHz-10MHz e.g. 2 or 8 MHz. At these frequencies the internal
capacities of the transistors which are of the order of a few picofarads
smooth the output waveform.

[0049] As is apparent from FIG. 4 which shows in a simplified diagram
output waveforms during a single switching operation, the output waveform
is such that the pulses can be switched progressively from energizing one
electrode as active electrode to energizing the other electrode as active
electrode, the change conveniently being stepwise in 4, 8 or 16 steps,
over-rapid switching from one site of stimulation to the other being
undesirable from the standpoint of the patient.

[0050] Electrical pulses applied to the body via skin surface electrodes
cause depolarization of the underlying nerve membrane, which causes the
propagation of an impulse along the nerve and contraction of the
associated muscle. The response of the nerve depends on the properties of
the applied stimulus. If the stimulus is too short, high stimulus
amplitude is required to bring about depolarization, and the amplitude of
the stimulus required can be reduced by increasing the threshold, but
only up to a maximum. The most efficient length of impulse is about 300
μs with little decrease in threshold beyond 1 ms, the required
currents being about 15-150 mA. A chain of pulses is required to produce
a fused tetanic contraction. As the pulse repetition frequency is
increased, the individual contractions of the muscles being stimulated
become closer together until at about 10 Hz fused contraction is
achieved. However, the user will still be aware of vibration due to the
individual pulses. By about 20 Hz vibration is reduced and a frequency of
30-40 Hz avoiding the user becoming aware of individual pulses while not
resulting in rapid muscle fatigue. A frequency of 40 Hz is suitable for
eliciting reflexors. An appropriate frequency can be selected for
individual patients. By slowing the rising and falling edges of the
stimulation envelope, the stimulus can be made more comfortable for the
patient, a ramp time of 1-2 s being suitable but some users with severe
spasticity requiring a ramp time of 6 s or above. [0051] Rising ramp
(0-2000 ms, default 200 ms) which allows the clinician to choose how
rapidly the stimulation rises to its maximum pulse width once a
stimulation output starts. There are three reasons for adjustment of this
parameter. In patients with spasticity in their calf muscles, a rapid
rise in pulse width may cause a rapid stretch of the calf, which may
result in a stretch reflex that opposes dorsiflexion and may appear as a
general stiffening of the calf or clonus spasm. A longer ramp helps to
prevent this happening. Some patients find a rapid rise of pulse width
uncomfortable. A longer ramp may be more acceptable. If dorsiflexion
occurs too soon, it is difficult for a patient to use his or her calf
muscles to push forward at terminal stance. A longer ramp may allow this
to happen. However, in all cases it is important that the stimulation
ramps fast enough to cause dorsiflexion when the foot is lifted. For this
reason, faster walkers will require shorter ramps. [0052] Extension
(0-2000 ms, default 200 ms) which allows a period of stimulation after
weight is returned to the heel switch (or taken off it in heel rise mode)
to be added. This enables an eccentric contraction in the anterior
tibialis, lowering the foot to the ground. If the extension is too short,
the ankle may lack control at the weight acceptance phase of walking and
audible slap may occur as the foot strikes the ground. Extension can also
be used to provide eversion for ankle stability in initial weight bearing
when there is excessive inversion. [0053] Falling ramp (0-2000 ms,
default 200 ms) is the interval during which the pulse width takes to
reach zero after the Extension has ended. It can be used with the
extension to control the movement of the foot after heel strike and
increase comfort. [0054] Time out period (300-6000 ms) is the maximum
time that stimulation can last for from a single footswitch or test
switch trigger. It may be set just a little longer than the longest
stride time taken by the user and is desirably long enough for activities
such as stair climbing but not so long that a user will be subject to
prolonged stimulation when weight is taken off the switch on sitting
down. [0055] Output waveform may be selected from symmetric and
asymmetric. When an asymmetrical biphasic waveform is used, the strongest
stimulation effect is under the active electrode. Placing the active
electrode over the common peroneal nerve and indifferent over the
anterior tibialis generally produces dorsiflexion with eversion. Swapping
the electrodes around gives more dorsiflexion and less eversion (see the
discussion above). In Symmetrical biphasic, the polarity of every other
pulse is reversed so that both electrodes have equal stimulation effect.
For some users this may produce a better balance of eversion and
inversion. Some people find this waveform more comfortable and/or are
less prone to skin reaction. The waveforms in FIG. 4 show pulses with
regions of opposite polarity but less than completely symmetrical so that
the balancing pulse is less than the main pulse, waveforms of this type
being found to be effective and avoiding skin irritation for many users.
If the polarity of the electrodes is swapped over diring the dourse of a
stream of stimulation pulses the degree of balance between dorsiflexion
and eversion can be controlled for each part of the gait cycle. The same
method will also work if the stimulator is used for other muscle groups
of the body e.g. in upper limb applications where the stimulator may be
used with an alternative trigger to the footswitch 18. [0056] Frequency
(20-60 Hz, default 40 Hz for dropped foot) may be selected to reduce
muscle fatigue and improve response e.g. in MS patients who may benefit
from higher or lower frequencies within the above range. [0057] Foot
switch operation on heel strike or heel rise. For dropped foot
correction, heel rise is more commonly used. The foot switch may be
placed under the heel of the affected side. This means all the equipment
is on the same side of the body and is considered more convenient by most
users. However, if foot contact is unreliable on the affected side, it
can be more effective to place the foot switch under the heel on the
opposite side which may give a more reliable trigger. In this case
stimulation needs to begin when weight is applied to the switch so the
heel strike setting is used. Some faster walkers also prefer this mode.
[0058] Timing mode. Adaptive Timing is a mode where stimulation is
started by a foot switch change (e.g. heel rise or heel strike) and ended
by a foot switch change (e.g. heel strike or heel rise). If the second
footswitch change does not occur before the set Time Out Period,
stimulation will end automatically. This timing mode adapts well to
walking speed changes and is used in most default settings including
dropped foot. Fixed time mode stimulation starts on a footswitch change
(e.g. heel rise or heel strike) but is ended after a fixed time set by a
time out period. This mode is used when foot contact is inconsistent and
gives unreliable triggering. It can be useful if the user is hesitant in
taking steps, taking weight on and off the footswitch as multiple
attempts are made. No time out: mode is similar to adaptive timing except
there is no maximum time for stimulation output which simply follows the
footswitch. An extension may still be added to the end of the stimulation
output. This mode is not normally used in dropped foot correction but may
be used for stimulating anti gravity muscles such as quadriceps or
gluteus maximus.

[0059] In FIG. 2 a voltage divider formed by foot switch 18 and digital
potentiometer 34 controlled by lines 32 from the microcontroller 20 form
a voltage divider connected between voltage rail 30 and earth. The output
is connected at 36 to an A/D converter input of the microcontroller 20.
The value of the potentiometer 34 is set to maintain the voltage at 36 at
a level such as to permit reliable detection of the open/closed state of
foot switch 18, the necessary value depending on the resistance of the
switch 18 which is variable according to the conditions to which the
switch is subject. Although the switch 18 is recommended to be fitted to
the underside of a cork insole, variability in the conditions to which
the switch is subject is unavoidable. The routine executed by the
microcontroller as regards the voltage divider is shown in FIG. 7 which
is believed to be self-explanatory.

[0060] The stimulator may be used for exercise prior to or as well as for
functional use. It may be used to treat other muscle groups e.g. those of
the upper limb e.g. the deltoid and triceps muscles which can be
stimulated using the scheme for switching active electrodes shown in
FIGS. 3 and 4. The footswitch trigger may be replaced with other forms of
trigger e.g. positional or proximity switches. Multiple stimulators may
be linked with wires or wirelessly to treat complex conditions e.g.
hemiplegia.

[0061]FIG. 5 shows an arrangement for two channel stimulation. Output
pulses are fed to the primary of output transformer 50 whose secondary 54
is connected to optical relay 60 switchable between first and second
output states depending on whether photodiode 58 is energized. In FIG. 6
the outputs of the first optical relay are connected to second and third
optical relays 62, 64 to provide outputs for four channels.

[0062] It will be appreciated that variations may be made in the
embodiments described herein without departing from the invention.